Maxigra Max

1. What is Maxigra Max and what is it used for

Maxigra Max contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. The medication works by helping to relax the blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. Maxigra Max helps achieve an erection only if there is prior sexual stimulation.

Maxigra Max is used to treat erectile dysfunction in adult men, i.e., impotence. It is the inability to achieve or maintain an erection sufficient for sexual intercourse.

Maxigra Max should not be taken by patients who do not have erectile dysfunction.

Maxigra Max is not intended for use by women.

If the patient does not experience improvement or feels worse after taking the medication, they should contact their doctor.

Before taking the medication, please read the leaflet carefully and familiarize yourself with the "Patient Information" attached to the packaging. To ensure safe use of the medication, please answer all questions in the questionnaire.

2. Important information before taking Maxigra Max

When not to take Maxigra Max

• If the patient is allergic to sildenafil or any of the other ingredients of this medication (listed in section 6).
• If the patient is taking medicines called nitrates, as their concurrent use may lead to a dangerous decrease in blood pressure. The patient should inform their doctor if they are taking any medications from this group. The nitrate group includes the following medications:
• nitroglycerin (Glyceroli trinitras) - e.g., Nitrocard, Nitromint, Sustonit, Nitroderm, Minitran
• isosorbide mononitrate (Isosorbidi mononitras) - e.g., Effox, Isosorbide mononitrate Vitabalans, Isosorbidi mononitras Accord, Mono Mack, Mononit, Monosan, Olicard retard
• isosorbide dinitrate (Isosorbidi dinitras) - e.g., Sorbonit
• pentaerythritol tetranitrate (Pentaerythrityli tetranitras) - e.g., Galpent, Pentaerythritol compositum. These medications are often used to relieve symptoms of angina pectoris ("chest pain"). In case of doubt, the patient should consult a doctor or pharmacist.
• If the patient is taking medicines or other agents that release nitric oxide (such as amyl nitrite, so-called "poppers"), as their concurrent use may also cause a dangerous decrease in blood pressure.
• If the patient is taking riociguat (e.g., Adempas). This medication is used to treat pulmonary hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by blood clots). It has been shown that phosphodiesterase type 5 (PDE5) inhibitors, such as Maxigra Max, enhance the blood pressure-lowering effect of this medication. If the patient is taking riociguat or is unsure, they should inform their doctor.
• If the patient has severe heart or liver disease.
• If the patient has had a stroke or heart attack in the past few months, or in cases of low blood pressure.
• If the patient has hereditary degenerative retinal disorders, such as retinitis pigmentosa.
• If the patient has ever experienced loss of vision due to non-inflammatory anterior ischemic optic neuropathy.

Warnings and precautions

Before starting to take Maxigra Max, the patient should discuss it with their doctor or pharmacist in the following cases:

• sickle cell anemia (a disorder affecting red blood cells), leukemia (a blood cancer), multiple myeloma (a bone marrow cancer);
• penile deformity or Peyronie's disease;
• heart problems. In this case, the doctor should assess whether the heart muscle condition allows for the additional effort associated with sexual activity;
• peptic ulcer disease;
• bleeding disorders (such as hemophilia).

If the patient experiences sudden vision loss or sudden loss of vision, they should stop taking Maxigra Max and immediately consult a doctor.

Maxigra Max should not be taken concurrently with other oral or topical treatments for erectile dysfunction.

Maxigra Max should not be taken concurrently with treatments for pulmonary arterial hypertension (PAH) using sildenafil or other phosphodiesterase type 5 (PDE5) inhibitors (e.g., tadalafil).

Special considerations for patients with renal or hepatic impairment

Patients with renal or hepatic impairment should inform their doctor. Patients with renal or hepatic impairment should not take a dose of the medication higher than 25 mg without consulting their doctor.

Children and adolescents

Maxigra Max should not be taken by individuals under the age of 18.

Maxigra Max and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.

The medications listed below may be marketed under different trade names. Therefore, the patient should carefully check the packaging and leaflet of the medication they are taking to determine the active substance.

Maxigra Max, film-coated tablets, may interact with certain medications, especially those used to treat chest pain. In case of a worsening condition requiring immediate medical attention, the patient should inform their doctor about taking Maxigra Max and the time of its administration. The patient should not take Maxigra Max concurrently with other medications without their doctor's recommendation.

The patient should not take Maxigra Max if they are taking medications from the nitrate group, as their concurrent use may lead to a dangerous decrease in blood pressure.

The nitrate group includes the following medications:

• nitroglycerin (Glyceroli trinitras) - e.g., Nitrocard, Nitromint, Sustonit, Nitroderm, Minitran
• isosorbide mononitrate (Isosorbidi mononitras) - e.g., Effox, Isosorbide mononitrate Vitabalans, Isosorbidi mononitras Accord, Mono Mack, Mononit, Monosan, Olicard retard
• isosorbide dinitrate (Isosorbidi dinitras) - e.g., Sorbonit
• pentaerythritol tetranitrate (Pentaerythrityli tetranitras) - e.g., Galpent, Pentaerythritol compositum.

The patient should always inform their doctor or pharmacist if they are taking nitrates used to treat angina pectoris ("chest pain").

The patient should not take Maxigra Max if they are taking medications or agents that release nitric oxide (such as amyl nitrite, so-called "poppers"), as their concurrent use may lead to a dangerous decrease in blood pressure.

If the patient is taking riociguat, they should inform their doctor or pharmacist.

In case of taking protease inhibitors (e.g., ritonavir, saquinavir) used to treat HIV infections, the patient should consult their doctor before taking Maxigra Max.

In case of taking alpha-adrenergic blockers before taking Maxigra Max, the patient should consult their doctor. In some patients taking alpha-adrenergic blockers (e.g., doxazosin, prazosin, terazosin) for high blood pressure or prostate enlargement, dizziness or lightheadedness may occur, which can be symptoms of low blood pressure caused by a drop in blood pressure when standing up or sitting down quickly. Such symptoms have occurred in some patients taking sildenafil and alpha-adrenergic blockers concurrently. Their occurrence is most likely within 4 hours of taking Maxigra Max. To reduce the risk of these symptoms, the patient should regularly take their fixed dose of alpha-adrenergic blockers before starting to take Maxigra Max. The doctor may also decide to use a lower initial dose of sildenafil (25 mg). In case of symptoms of low blood pressure (dizziness, lightheadedness, feeling of impending faint), the patient should first lie down or sit and wait for the symptoms to pass; drinking water or getting some fresh air may also help. The patient should avoid standing up or sitting down quickly.

If the patient is taking ketoconazole, erythromycin, cimetidine, they should consult their doctor before taking Maxigra Max.

If the patient is taking medications containing sacubitril with valsartan, used to treat heart failure, they should inform their doctor or pharmacist.

Maxigra Max with food, drink, and alcohol

Maxigra Max can be taken with or without food.

However, taking Maxigra Max while consuming large meals may prolong the time needed for the medication to start working.

The ability to achieve an erection may be temporarily impaired after consuming alcohol. To maximize the therapeutic benefits of Maxigra Max, the patient should not consume large amounts of alcohol before taking the medication.

Pregnancy, breastfeeding, and fertility

Maxigra Max is not intended for use by women.

Driving and using machines

Maxigra Max may cause dizziness and vision disturbances. Patients should be aware of how they react to Maxigra Max before driving or operating machinery.

Maxigra Max contains sodium

The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Maxigra Max

This medication should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult a doctor or pharmacist.

If the patient has previously taken medications containing sildenafil in a dose of 50 mg or higher, the recommended dose is 50 mg. Otherwise, Maxigra Max in a dose of 50 mg should only be taken if the patient did not experience a satisfactory effect (i.e., did not achieve an erection sufficient for sexual intercourse) after taking sildenafil in a dose of 25 mg. The condition is to obtain the result "I can take Maxigra Max containing sildenafil 50 mg" from the attached questionnaire.

There are patients for whom a dose of 25 mg is sufficient to achieve a satisfactory therapeutic effect. These patients should remain at a dose of 25 mg, taken as needed, approximately one hour before planned sexual activity.

The doctor may recommend a different dosing regimen after consultation.

Maxigra Max should not be taken more than once a day.

The patient should not take Maxigra Max concurrently with other medications containing sildenafil (e.g., Maxigra Go, Sildenafil Medana, Viagra).

Maxigra Max should be taken approximately one hour before planned sexual activity. The tablet should be swallowed whole, with a glass of water.

If the patient feels that the effect of Maxigra Max is too strong or too weak, they should consult their doctor or pharmacist.

Maxigra Max enables an erection only if there is prior sexual stimulation. The time it takes for the medication to work varies from patient to patient, usually ranging from half an hour to one hour. The effect may occur later if the medication is taken after a large meal.

The patient should contact their doctor if they do not achieve an erection or if the duration of the erection is not sufficient for sexual intercourse after taking Maxigra Max.

Taking a higher dose of Maxigra Max than recommended

The patient may experience more frequent side effects, and they may be more severe.

Taking a dose higher than 100 mg does not increase the effectiveness of the medication.

Do not take more tablets than indicated in the patient leaflet.

The patient should contact their doctor in case of taking more tablets than recommended.

In case of any further doubts about the use of this medication, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medications, Maxigra Max can cause side effects, although not everybody gets them.

Side effects reported in connection with the use of Maxigra Max are usually mild or moderate and short-lived.

In case of experiencing any of the following side effects, the patient should stop taking Maxigra Max and seek immediate medical attention:

• An allergic reaction occurs uncommonly(may occur in less than 1 in 100 patients). Symptoms: rapid, wheezing breathing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.
• Chest pain - occurs uncommonly. If it occurs during or after sexual intercourse:
• the patient should sit half-up and try to relax,
• not take nitratesto relieve chest pain.
• Prolonged and sometimes painful erections - occur rarely(may occur in less than 1 in 1000 patients). If the erection lasts for more than 4 hours, the patient should contact their doctor immediately.
• Sudden vision loss or sudden loss of vision - occur rarely.
• Severe skin reactions - occur rarely. Symptoms may include severe peeling and swelling of the skin, blistering in the mouth, on the genitals, and around the eyes, fever.
• Seizures or convulsions - occur rarely.

Other side effects:

Very common(may occur in more than 1 in 10 patients):

• headache.

Common(may occur in less than 1 in 10 patients):

• nausea, sudden flushing of the face, hot flushes (symptoms include a feeling of heat in the upper part of the body), indigestion,
• visual disturbances, blurred vision, color tinge to vision,
• stuffy nose, dizziness.

Uncommon(may occur in less than 1 in 100 patients):

• vomiting, skin rash,
• eye irritation, conjunctivitis, eye pain, flashes of light, abnormal vision, sensitivity to light, tearing,
• palpitations, rapid heart rate, high blood pressure, low blood pressure,
• muscle pain, somnolence, decreased sensitivity to touch, vertigo, ringing in the ears,
• dry mouth, stuffy or blocked sinuses, nasal congestion (symptoms include runny nose, sneezing, and stuffy nose),
• upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn),
• blood in urine, pain in arms or legs, nosebleeds, feeling of heat and feeling of fatigue.

Rare(may occur in less than 1 in 1000 patients):

• fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to part of the brain,
• feeling of tightness in the throat, numbness of the lips,
• bleeding at the back of the eye, double vision,
• reduced sharpness of vision, abnormal sensations in the eye, swelling of the eyes or eyelids,
• small particles or spots in the field of vision, seeing halos around light sources,
• pupil dilation, abnormal discoloration of the white of the eye,
• penile bleeding, presence of blood in semen, dry nose, swelling inside the nose,
• feeling of irritability and sudden loss of hearing.

After the medication was placed on the market, rare cases of unstable angina (heart disease) and sudden death have been reported. It is essential to note that in most, but not all, men who experienced these side effects, heart problems existed before taking sildenafil. It is not possible to determine whether these side effects were related to the use of the medication containing sildenafil.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C

02-222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, it is possible to gather more information on the safety of the medication.

5. How to store Maxigra Max

The medication should be stored out of sight and reach of children.

There are no special recommendations for storing the medication.

The medication should not be used after the expiration date stated on the packaging and blister. The expiration date refers to the last day of the specified month.

Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Maxigra Max contains

• The active substance of the medication is sildenafil. Each tablet contains 50 mg of sildenafil (in the form of citrate).
• Other ingredients of the medication are:
• Core: mannitol (E421), crospovidone (type A), povidone (K30), colloidal silica, cornstarch, magnesium stearate, sodium lauryl sulfate.
• Coating: hypromellose, macrogol 6000, titanium dioxide, talc, indigo carmine lake (E132).

What Maxigra Max looks like and what the pack contains

The film-coated tablets are round, biconvex, and blue.

The packaging contains 1, 2, or 4 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Date of last revision of the leaflet: